FDA 510(k) Application Details - K040766

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K040766
Device Name Source, Brachytherapy, Radionuclide
Applicant INTERNATIONAL BRACHYTHERAPY S.A.
6000 LIVE OAK PARKWAY
SUITE 107
NORCROSS, GA 30093 US
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Contact RUTH FEICHT
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 03/25/2004
Decision Date 07/22/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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